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Goal-directed MIS Simulation Training With the LTB-Curriculum Prior to First Operations on Patients: Study Protocol for a Multi-centre Randomized Controlled Validation Trial (NOVICE) (NOVICE)

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ClinicalTrials.gov Identifier: NCT03040544
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Thomschewski, University Hospital Schleswig-Holstein

Brief Summary:

Background: Laparoscopic surgical procedures have become increasingly established in operative medicine. They require special motor, haptic, and spatial-visual skills to perform the interventions safely and effectively. These minimally invasive surgery (MIS) basic skills are often learned in the operating room (OR) on the patient. This is economically inefficient and can be improved with regard to patient safety. Against the background of this problem, various simulators and video-box trainer have been developed in order to train laparoscopic basic skills outside the OR. The Lübecker Toolbox (LTB) curriculum is a video-based trainer including standardized and validated exercises with defined targets, based on the skills of experts MIS. Conducting MIS training outside the OR prior to performing the first MIS procedures on patients could be a sensible and valuable contribution to effective surgical education. An evidence of effectiveness in the practice transfer could have a considerable relevance with regard to the integration of MIS training programs into surgical education programs.

Aim of the study: The aim of the study is to investigate whether surgical residents without previous active experience in MIS are able to improve laparoscopic skills in MIS procedures in the OR, if they have successfully completed the LTB curriculum.

In the multicentric prospective study, will be conducted with surgical residents (SR) without prior active experience in MIS (n=14). After the SR have completed their first laparoscopic cholecystectomy (CHE), they will be randomized into two groups: 1) The intervention group will perform the LTB-Curriculum, whereas 2) the control group will not undergo any MIS training. After 6 weeks, both groups will perform the second laparoscopic CHE. Improvements in operative performance (between CHE I and CHE II) will be evaluated according to the Global Operative Assessment of Laparoscopic Skill (GOALS) Score (primary endpoint).


Condition or disease Intervention/treatment Phase
Minimally Invasive Surgery Basic Skills Procedure: LTB-Curriculum Procedure: Laparoscopic cholecystectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Goal-directed Minimally Invasive Surgery Simulation Training With the Lübeck Toolbox-Curriculum Prior to First Operations on Patients: Study Protocol for a Multi-centre Randomized Controlled Validation Trial (NOVICE)
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : May 21, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: LTB-Curriculum
First group/arm undergo MIS training according to the LTB curriculum after the first own laparoscopic cholecystectomy in the OR as a baseline. After 6 weeks, the participants in this group/arm will perform their second CHE. The video recordings of the MIS procedures will be analysed and compared using the Global Operational Assessment of Laparoscopic Skill (GOALS) score.
Procedure: LTB-Curriculum
The Lübeck Toolbox (LTB) curriculum has a structured training program, in which the laparoscopic basic skills are to be learned in six consecutive exercises. In doing so, the curriculum has precise targets for each of the six exercises based on the abilities of 15 MIS experts as a benchmark. The LTB curriculum is thus a structured training program with clear objectives that enable the technical learning of MIS basic skills comparable to the expert level.

Procedure: Laparoscopic cholecystectomy
Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS

Active Comparator: no LTB-Curriculums
Second group/arm will not undergo any MIS trains after their first laparoscopic CHE in the OR. After 6 weeks, the participants in this group/arm will perform their second CHE. The video recordings of the MIS procedures will be analysed and compared using GOALS score.
Procedure: Laparoscopic cholecystectomy
Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS




Primary Outcome Measures :
  1. Global Operative Assessment of Laparoscopic Skill (GOALS)-Score [ Time Frame: end of inclusion of all participants ]
    The GOALS score is an internationally established score for evaluating the MIS skills of a surgeon


Secondary Outcome Measures :
  1. operation time [ Time Frame: 8-12 weeks ]
    operation time of CHE I and CHE 2

  2. percentage of the participants operating time in the total time of the CHE [ Time Frame: 8-12 weeks ]
    percentage of participants operating time in the total time of the CHE I and CHE II

  3. number of takeovers by the specialist assisting the CHE [ Time Frame: 8-12 weeks ]
    experienced consultant surgeon will assist the CHE. The specialist can take over the operation at any time and perform surgical steps independently, according to his/her judgement with regard to the individual situation

  4. potential conversion to laparotomy [ Time Frame: 8-12 weeks ]
    potential conversion of the MIS CHE to open surgery


Other Outcome Measures:
  1. sex of participant [ Time Frame: 8-12 weeks ]
    sex of participant (male or female)

  2. dominant hand of participant [ Time Frame: 8-12 weeks ]
    dominant hand of participant (right or left)

  3. age of participant [ Time Frame: 8-12 weeks ]
    age of the participants

  4. correlation with activities and hobbies [ Time Frame: 8-12 weeks ]
    in particular playing an instrument, handicrafts and computer games

  5. inter-rater reliability [ Time Frame: 8-12 weeks ]
    possible differences and bias between video ratings by calculation



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • no motor or sensory restrictions when using surgical instruments surgical instruments.
  • no previous performed MIS simulation training
  • no previous performed MIS procedure ( any previous assisted MIS procedures are not an exclusion criterion)
  • residents in surgical education for general or visceral surgery in Germany

Exclusion Criteria:

  • The participant are not allowed to perform any other MIS training programs during the study period
  • Before the start of the study, participants are not allowed to have performed any prior MIS simulation training or any MIS procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040544


Contacts
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Contact: Michael Thomaschewski, MD +491784007135 Michael.Thomaschewski@uksh.de

Locations
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Germany
Medical University Center Schleswig-Holstein Campus Lübeck, Department of surgery Recruiting
Lubeck, Schleswig-Holstein, Germany, 23538
Contact: Michael Thomaschewski, MD    +491784007135    Michael.Thomaschewski@uksh.de   
Sponsors and Collaborators
University Hospital Schleswig-Holstein
Investigators
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Study Director: Claudia Benecke, MD Medical University Center Schleswig-Holstein Campus Lübeck
Study Director: Tilman Laubert, MD Medical University Center Schleswig-Holstein Campus Lübeck
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Responsible Party: Michael Thomschewski, Dr., University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03040544    
Other Study ID Numbers: NOVICE trial
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Thomschewski, University Hospital Schleswig-Holstein:
minimally invasive surgery
video-based trainer
laparoscopic
simulation training
surgical education